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KMID : 0616620040100010081
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Journal of Soonchunhyang Medical College
2004 Volume.10 No. 1 p.81 ~ p.84
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Bioequivalence study of a generic aceclofenac tablet preparation
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Kwon Jun-Tack
Kim Hyung-Kee
Sohn Dong-Ryul
Yom Yoon-Ki
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Abstract
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The bioequivalence of generic aceclofenac(Anacle®, Korea Pharma Co.) tablet to the aceclofenac tablet(Arital®, DaeWoong Pharmaceutical Co.) as a reference drug. Single dose of 100 mg aceclofenac was administered to 20 healthy male volunteers in a balanced, randomized crossover design with a washout between the two study periods. Blood samples were collected up to 12 hours and plasma concentration of aceclofenac was measured by well validated reverse phase high-performance liquid chromatography. Pharmacokinetic parameters were analyzed by non-compartmental analysis and ANOVA test was used for the statistical analysis of parameters. No statistically significant formulation, period, or sequence effect was encountered. Ninety percent confidence intervals of log transformed C_(max) and AUC_(t) were comprised in the stipulated 0.80-1.25 range. These results suggest that test formulation of aceclofenac is bioequivalent with the reference, both formulations in 100 mg tablet.
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KEYWORD
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bioequivalence, bioavailability, aceclofenac, hplc
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